- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817917
Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province
Seroprevalence of Neutralizing Antibodies Against Japanese Encephalitis Virus Among 6 Years Old Children With 5 Different Immunization Strategies in Zhejiang Province, China: An Open-labeled, Ambidirectional Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Zhejiang
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Lishui, Zhejiang, China, 323000
- Liandu Center for Disease Control and Prevention
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Quzhou, Zhejiang, China, 324000
- Kecheng center for disease control and prevention
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Wenzhou, Zhejiang, China, 325400
- Pingyang center for disease control and prevention
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants aged ≥ 72 months to < 75 months.
- Participants have completed routine immunization schedules in time.
- Participants are healthy native residents.
- Parents/guardians can understand the protocol requirements, provide informed consent, accept all scheduled visits, and comply with all trial procedures.
Exclusion Criteria:
- History of neurological diseases or related symptoms.
- An acute illness with fever (temperature ≥ 37.1℃) or any acute onset of chronic diseases.
- Known impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin in the past 3 months.
- Known allergy to any constituent of the vaccine.
- Have been injected with other vaccines or any clinical trial drugs in the past 4 weeks.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3JEV-I (Group 1)
Retrospective: 3 doses of JE vaccines. 2 doses of Inactivated JE Vaccine (JEV-I, 7-10 days apart) at 8 months of age and 1 dose of JEV-I at 2 years old. Prospective: 1 booster dose of JEV-I at 6 years old. |
The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies.
For participants from Group 1 and Group 2 who haven't completed the JE immunization schedules, a booster dose of JEV-I will be administered at 6 years old.
|
Experimental: JEV-L+JEV-I (Group 2)
Retrospective: 2 doses of JE vaccines. 1 dose of JE attenuated live vaccine (JEV-L) at 8 months of age and 1 dose of JEV-I at 2 years old. Prospective: 1 booster dose of JEV-I at 6 years old. |
The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies.
For participants from Group 1 and Group 2 who haven't completed the JE immunization schedules, a booster dose of JEV-I will be administered at 6 years old.
|
Experimental: JEV-L+2JEV-I (Group 3)
Retrospective: 3 doses of JE vaccines. 1 dose of JEV-L at 8 months of age and 2 dose (7-10 days apart) of JEV-I at 2 years old. |
The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies.
Participants from Group 3-5 have completed the JE immunization schedules with JEV-I or/and JEV-L.
No prospective intervention will be given.
|
Experimental: 2JEV-I+JEV-L (Group 4)
Retrospective: 3 doses of JE vaccines.
2 doses of JEV-I (7-10 days apart) at 8 months of age and 1 dose of JEV-L at 2 years old.
|
The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies.
Participants from Group 3-5 have completed the JE immunization schedules with JEV-I or/and JEV-L.
No prospective intervention will be given.
|
Experimental: 2JEV-L (Group 5)
Retrospective: 2 doses of JE vaccines.
2 doses of JEV-L respectively administered at 8 months of age and 2 years old.
|
The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies.
Participants from Group 3-5 have completed the JE immunization schedules with JEV-I or/and JEV-L.
No prospective intervention will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportions of seropositivity of neutralizing antibodies against JE at the age of 6
Time Frame: At the age of 6. Test immediately after enrollment by a dose of blood sample.
|
Defined as any positive antibody (neutralizing antibody titers ≥1:10) response in children aged 6.
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At the age of 6. Test immediately after enrollment by a dose of blood sample.
|
Geometric Mean Titers (GMTs) or Median antibody titers for children aged 6 years
Time Frame: At the age of 6. Test immediately after enrollment by a dose of blood sample.
|
Neutralizing antibody titers by plaque-reduction neutralization tests (PRNT).
|
At the age of 6. Test immediately after enrollment by a dose of blood sample.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion rates of the booster dose of JEV-I for Group 1 and Group 2
Time Frame: before and 28-35 days after the booster dose.
|
Defined as any positive antibody (neutralizing antibody titers ≥1:10) response in children who were seronegative prior to the booster dose, or at least a four-fold increase for children who had pre-existing positive antibodies.
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before and 28-35 days after the booster dose.
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Proportion of seropositivity of neutralizing antibodies against JE after the booster dose for Group 1 and Group 2.
Time Frame: 28-35 days after the booster dose.
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Defined as any positive antibody (neutralizing antibody titers ≥1:10) response after the booster dose.
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28-35 days after the booster dose.
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Geometric Mean Titers (GMTs) or Median antibody titers after the booster dose for Group 1 and Group 2.
Time Frame: 28-35 days after the booster dose.
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Neutralizing antibody titers by PRNT.
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28-35 days after the booster dose.
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Safety of the booster dose for Group 1 and Group 2
Time Frame: From inoculation to 30 days after the inoculation.
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The occurrence of adverse events for the booster dose
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From inoculation to 30 days after the inoculation.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
- Vaccine-Preventable Diseases
Other Study ID Numbers
- ZJCDC20210317
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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